Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00747955
First received: September 5, 2008
Last updated: May 21, 2014
Last verified: April 2014
  Purpose

This study will evaluate new assessment tools and equipment and new ways of using existing tools and equipment in the NIH Clinical Center s Rehabilitation Medicine Department in order to maximize patients function. The Department assesses and treats NIH patients with chronic pain, problems in walking or getting around, activities of daily living, performing tasks needed for jobs or hobbies, communicating and chewing and swallowing.

Children and adults of all ages with disabilities and healthy normal volunteers may be eligible for this study.

The following kinds of assessments are evaluated in this study:

Assessments of Impairments

Impairments are problems such as loss of movement, weakness or loss of sensation. Assessments may include measurements of range of motion, strength, sensation, pain, joint stability or mobility, joint angles, limb and girth, gait, exercise tolerance, stamina, or ultrasound imaging of muscle and swallowing function.

Assessments of Function and Performance

Functional and performance assessments look at how well subjects perform actions, such as walking or getting around, dressing, or preparing meals. They may include evaluations of activities of daily living, leisure activities, fatigue, vocational activity, school activity, coping skills, and quality of life. The assessments may be done by questionnaires or interviews and by watching subjects perform the activities.

Assessments of Treatment Techniques

Treatment techniques are assessed by evaluating methods and equipment used to treat patients with impairments or problems with function. They may evaluate, for example, the use of heat, cold, strengthening exercises, fitness exercises, TENS units, splinting and orthotics, or shoe modifications.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Assessments of Motor Performance, Physical Impairments and Functional Abilities

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Efficiency of administration feasibility, reliability, reproducibility, precision, sensitivity, specificity, tolerability and/or validity of the clinical evaluation or functional assessment equipment.

Estimated Enrollment: 500
Study Start Date: August 2008
Detailed Description:

The purpose of this study is to evaluate sensitivity of an EEG measurement system to discriminate between spatial-temporal EEG data collected at two different treadmill walking tasks tasks with/without voluntary control of walking speed. We hypothesize that the BrainAmp DC will be able to differentiate the two tasks where subjects perform physically same walking (speed, step length, and cadence) but have different cognitive activities. We plan to monitor and compare EEG signals during two types of treadmill walking tasks 1) typical treadmill walking where treadmill changes walking speed and subjects adjusts to it and 2) subject driven treadmill walking where subjects voluntarily changes walking speed. It is necessary to complete sensitivity evaluation of the EEG measurement system in order to go on to evaluate potential effectiveness of different treadmill training methods by comparing brain activities in two treadmill tasks. This has the possibility to provide guidelines for RMD professionals to design more effective gait training interventions for NIH Clinical Center patients.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Healthy adults between the ages 18-80 who are able to walk on a treadmill without a cane, walker or other assistive device.

Able to safely participate in the use of the specific equipment or clinical evaluation.

Able to provide informed consent or, if a minor, for the guardian to provide informed consent.

EXCLUSION CRITERIA:

Any condition which would result in injury or pain from the performance of the clinical evaluations or use of the evaluation equipment.

Subjects at higher risk of falling (e.g., pregnant women in the 3rd trimester, and obese patients with Body Mass Index over 30 kg/m2) will be excluded.

Children will be excluded because the treadmill controller is designed and tuned for adult population; therefore, children might not be able to properly control the might not be able to complete the task by controlling self-selected speed on the instrumented treadmill, placing them at increased risk of falling.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747955

Contacts
Contact: Scott M Paul, M.D. (301) 496-4733 spaul1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Scott M Paul, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00747955     History of Changes
Other Study ID Numbers: 080205, 08-CC-0205
Study First Received: September 5, 2008
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Human Performance
Physical Disability
Functional Outcome Measures
Health Volunteer
HV

ClinicalTrials.gov processed this record on July 28, 2014